Clinical trial · Interventional
Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
NCT04303325CI-TRIAL-00079009ESPOD-BIunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esketamine | Drug | — | UNRESOLVED |
| Saline Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
- interventionNames
- Drug: Saline Solution
- type
- ACTIVE_COMPARATOR
- label
- Esketamine
- description
- All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine.
- interventionNames
- Drug: Esketamine
Primary outcomes (1)
- measure
- Montgomery-asberg Depression Rating Scale score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * At least18 years and pre-menopausal; * scheduled to undergo elective breast cancer operation; * American Society of Anaesthesiologists (ASA) risk classification I-II. * Montgomery-asberg Depression Rating Scale (MADRS) score ≥22 Exclusion Criteria: * Cognitive difficulties * Partial or complete gastrectomy * Previous esophageal surgery * Inability to conform to the study's requirements * Ongoing participation or participation in another study \<1 month ago
References
Publications (0)
Data not yet available
No reference posted for this study.